We all look forward to the Christmas holidays. Wrong. Not all of us do. But many who are Christian and Jewish do, or who live in a country that celebrate this event. So, I am not going to go into the history books, quote from the Bible or even sing a Christmas carol (most are…

Human beings are generally quite positive animals. We, as a species are one of the few species that continuously improve ourselves and our surroundings. We are by far though the quickest evolving animals right now. This past weekend, we have been remembering the past one-hundred years since Armistice Day in 1918. To think that this…

Understanding users and how they use medical devices is important if you want to involve usability or human factors engineering as a prediction tool for how they may be used in real life. Researching and evaluating users in theory and practice with medical devices should give confidence in the potential uptake and use, which it…

I live at home with my family, a number of pets and luckily for myself and my family, very few medical devices. But as I age, I expect to be bringing home from hospitals and pharmacies more home-use medical devices – especially if hospital care is shifting towards home-based treatments and rehabilitation. This I do…

This is a continuation of part 1 and looks at more usability requirements. Section 14.2. “Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible; a) the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features,…

Whilst the Medical Device Directive (MDD) had a few mentions of the word “usability”, it was not back in 1993 when it was written, a commonly used term. More often, it was the term “ergonomic” that was used, and this word did make a few appearances in the Essential Requirements (Annex I) of the 1993…

Often within organisations, the Marketing function and the Research and Development functions act collaboratively to define the opportunity space for the next product. Market research is often performed at the very front end of the development process – to define the need, quantify its purpose, return on investment, and to ensure the organisation understands what…

New guidance from the FDA focuses on human factors in drug products where there is already a reference listed drug (RLD). Enhancing the formulation, consistency, quality and effectiveness of medicines is often seen as continuous improvement – bettering the clinical outcome of how the medicine received by our human bodies. Frequently though, the human…

Does sound matter in medical devices? This question may be obvious and perhaps unnecessary. Incorporating sounds in consumer products is a common design practice – in particular in electronics, but when it comes to medical devices the answer is not so obvious and it depends on a series of human factors – especially use safety.…